Administrative reconsideration and hierarchical review against a decision
appeal.administrative-reconsideration-and-hierarchical-review
- Statement
Administrative acts that end a procedure, prevent its continuation, produce defenselessness, harm subjective rights or cause irreparable damage may be challenged directly by the administrative route. The person may file a recurso de reconsideración before the organ that issued the act, which must decide within thirty days, and a recurso jerárquico before the competent Minister — in the central administration — without needing to have filed a reconsideración first, which must equally be decided within thirty days. If either appeal is not decided within the period, the interested party may treat it as tacitly denied and go, at its option, to the contentious-administrative jurisdiction without a preclusive deadline. Administrative appeals are optional, and filing one does not suspend the challenged act, although the reviewing organ may order its suspension of its own motion or on request.
- Article
Arts. 47, 49, 50, 51, 53 y 54
Conditions
- Ley 107-13 is the general administrative-procedure statute of the Dominican State; it creates the remedy available against DIGEMAPS and MSP decisions, not a DIGEMAPS-specific appeal, and is cited as the general remedy.
- The reviewing organ may confirm, modify or revoke the challenged act, or order the procedure to be re-run for procedural defects, and may never worsen the legal position of the appellant (art. 52).
- Suspension of the challenged act may be granted where execution could cause grave harm to the interested party or where the challenge is founded on nullity by operation of law, and a guarantee may be required (art. 50).
- The choice of the contentious-administrative route makes the administrative appeal unavailable, but filing an administrative appeal does not prevent later going to the courts once it is decided or the decision period has run (art. 51).
Spanish. Art. 53, verbatim: 'Los actos administrativos podrán ser recurridos ante los órganos que los dictaron en el mismo plazo de que disponen las personas para recurrirlos a la vía contencioso-administrativa.' and its Párrafo: 'El órgano competente para resolver el recurso administrativo dispondrá de un plazo de treinta (30) días para dictar su decisión. Si el recurso de reconsideración no fuera resuelto dentro del plazo fijado, el interesado podrá reputarlo denegando tácitamente, pudiendo interponer a su opción el recurso jerárquico, si procede, o el contencioso administrativo, sin plazo preclusivo.' Art. 54, verbatim: 'Contra los actos dictados por órganos sujetos al control jerárquico de otros superiores podrá interponerse recurso jerárquico, sin que sea necesario haber deducido previamente recurso de reconsideración.' and Párrafo III: 'La interposición de un recurso jerárquico tendrá que efectuarse en el mismo plazo de que disponen las personas para interponer el recurso contencioso administrativo. El recurso deberá ser en todo caso resuelto en un plazo no mayor de treinta (30) días. Si el recurso jerárquico no fuera resuelto dentro del plazo fijado, el interesado podrá reputarlo denegado tácitamente, pudiendo interponer, sin plazo preclusivo, el recurso contencioso administrativo.' Art. 47, verbatim: 'Los actos administrativos que pongan fin a un procedimiento, imposibiliten su continuación, produzcan indefensión, lesionen derechos subjetivos o produzcan daños irreparables podrán ser directamente recurridos en vía administrativa.' The source is the full text of Ley No. 107-13 published by the Poder Judicial of the Dominican Republic; its heading reads 'Ley No. 107-13 sobre los Derechos de las Personas en sus Relaciones con la Administración y de Procedimiento Administrativo. G. O. No. 10722 del 8 de agosto de 2013.'
Completeness check, deficiency notice and re-entry of a sanitary registration application
submission.deficiency-notice-and-re-entry
- Statement
A sanitary-registration application for a sanitary product is prepared from DIGEMAPS's published requirements list and filed online or in person at the Dirección de Gestión de Servicios al Usuario of the Ministerio de Salud Pública. That directorate confirms whether the application is complete — accepting it if it is, and notifying the applicant of the missing data or documentation if it is not — and the application is then entered and sent to DIGEMAPS for evaluation in the corresponding area, with the answer returned through the same directorate for delivery to the applicant. An application that was found non-conforming may be re-entered once the applicant has completed the observations received.
- Article
Procedimiento a seguir
Conditions
- The same 'Procedimiento a seguir' text is published on both the registration and the renewal service pages for sanitary products, so the deficiency-and-re-entry route applies to renewal as well as to first registration.
- The procedure described is an administrative completeness check at the front office; it does not state any substantive right of reply, hearing or appeal against a refusal, which is why the general administrative remedies are recorded as a separate fact.
- The registration service page also fixes the fee at RD$ 9,000 'Para Medicamento' and the response time at 90 días laborables; those are D14/D15 material and are not claimed here.
Spanish. Verbatim from the registration service page, 'Procedimiento a seguir': 'La Dirección de Gestion de Servicios al Usuario confirma si la solicitud está completa, en caso de estar completa la acepta y en caso de que no, notifica al usuario cuales son los datos o documentación faltante para ser completada.' and 'En el caso de las solicitudes no conformes, después que el usuario completa las observaciones recibidas, puede reingresar la solicitud.' — 'The Dirección de Gestión de Servicios al Usuario confirms whether the application is complete; if it is complete it accepts it, and if it is not it notifies the user of the data or documentation missing for it to be completed.' / 'In the case of non-conforming applications, once the user has completed the observations received, the application may be re-entered.' The same page's 'Descripción del servicio' states: 'Obtención del Registro Sanitario. Este requisito es obligatorio para la elaboración, fabricación, producción, importación, envase, almacenamiento, transportación, promoción, distribución y uso de los productos sanitarios en el país.'
